MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD SYRINGE 10ML LS 22GA 1-1/4IN TW

Catalog Number 301304

Device Problem Material Twisted/Bent (2981)

Patient Problem No Information (3190)

Event Date 03/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that bd syringe¿ 10ml ls 22ga 1-1/4in tw had a bent needle hub.

Manufacturer Narrative

Investigation: one photo was received.The bent needle hub of syringe; as stated as the reported code was confirmed with the returned photo.However, sample returned is required for further investigation.Based on the dhr review, there were no rejects related to the reported defect condition for the assembled needle during inspection.Unable to confirm the nonconformance as samples were not returned for evaluation.Therefore, the root cause could not be determined.

Event Description

It was reported that bd syringe¿ 10ml ls 22ga 1-1/4in tw had a bent needle hub.

• Brand Name: BD SYRINGE 10ML LS 22GA 1-1/4IN TW
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8437840
• MDR Text Key: 139434558
• Report Number: 8041187-2019-00242
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 301304
• Device Lot Number: 8267420
• Date Manufacturer Received: 03/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other